PDUFA IV Meeting Announcement

January 16, 2007

In today’s Federal Register, there is a whopping entry published from FDA regarding that publishes proposed recommendations for PDUFA IV that will cover years 2008-2012. Whopping refers to its length- 11 pages in PDF! It makes good reading if you are interested in making the commitment, if not, I’ve summarized it for you below.

The FDA is required to publish these proposed regulations and to hold a meeting to garner public input. That meeting is now set for February 16, 2007 from 9 A.M. until 5 P.M. and will be held at the Grand Hyatt Washington at Washington Centre, 1000 H Street, Washington, D.C. 20001. If you plan on attending, you much register by February 2, according to the notice, however they fail to state how one registers. If you have questions, however, the contact listed is Ann.Sullivan@fda.hhs.gov or her telephone number at 301-827-5887.

If you can’t attend, you can supply written comment and the FDA is required to hold a 30 day comment period. If you are using snail mail – you would send your comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852 or, if you are hip to the 21st Century, you can submit them electronically to the open FDA docket.

The notice outlines a very complete history of PDUFAs I, II and III and sets out an outline of PDUFA IV. It then outlines the various meetings held with stakeholders over the course of time reflecting what was required of PDUFA IV, including meetings with consumer groups and professional groups. As a result, they are publishing what they want from PDUFA IV, which fall into three categories: (i) ensuring the sound financial footing of the human drug review program; (ii) enhancing pre-market review of applications, and (iii) modernizing and transforming post-marketing surveillance. They also introduce another element – to review DTC television commercials. There is a table in the notice to describe the commitment of resources to each activity, without the DTC component, which is noted in a later, separate section.

I am a believer in relatively short postings, therefore for more detail and to see the tables, click on the above link.

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Eye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.